Owns the deviation investigation process for assigned deviations by applying technical, quality and process skills to conduct investigations. The deviation owner will lead the investigation of deviations that occur in operations and are responsible for authoring the investigation. Partners with quality assurance, quality control, operations, engineering, maintenance, calibration, safety and supplier quality management to ensure appropriate and timely determination of scope, product impact, root cause and corrective actions. Interacts will all levels of staff and provides status updates as well as present the strategy for closure of deviations. Manage several investigations at a time.
Determine scope, product impact, root cause and corrective actions for deviations from manufacturing procedures by interviewing, sampling, and applying the use of quality tools and techniques.
Collect, compile and analyze relevant data during the investigative process to ensure objective support for investigation outcomes.
Determine appropriate corrective actions and preventative actions (CAPAs) to prevent reoccurrence of the deviation with realistic timelines for completion.
Foster collaborative relationships focused on high quality investigations, meaningful corrective actions and the reduction of deviation generation rate.
Set up and run meetings with cross functional teams.
Close deviations in a timely manner to meet business and compliance needs.
Work with minimal supervision to drive deviations to closure.
Author and manage the investigations to meet key timing commitments, with well-investigated and well-documented deviation reports.
Puts complex thoughts and issues into writing in such a manner than an educated, but uninformed reader can understand and make decisions based on the written investigation report.
Work with the Manufacturing Science & Technology, Subject Matter Experts and Quality Approvers to determine the breadth and scope of the investigation, to identify the appropriate root cause, implement corrective actions, complete trending analysis, and recommend product disposition.
Present and defend investigations during regulatory inspections, as required.
Illustrate strong communication, project management and leadership skills, including the ability to interact and influence others at various levels of the organization.
Must meet the criteria/requirements for certification as a Deviation Writer within 120 days of starting in this position.
Performs other duties as assigned
Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)
0-3 years experience with BA degrees. 5 years of manufacturing experience with an Associates degree or a minimum of 8 years manufacturing experience and equivalent in related area. Experience in a regulated environment such as medical devices, pharmaceuticals or biotech industry. Must have a thorough understanding of the pharmaceutical/biotech manufacturing process and equipment, preferably solid oral dosage, and current Good Manufacturing Practices (cGMPs). Must have good analysis, troubleshooting, and investigation skills.